Join us as a Quality Engineer and play a crucial role in ensuring our products are developed in compliance with standards, regulations and engineering best practices. You will be a key member of our growing QA and V&V team, upholding the integrity and reliability of our work while making a significant impact on potentially lifesaving products.

In this Role, You Will:

  • Develop, implement, and maintain quality assurance processes, systems, and documentation to ensure compliance with FDA, ISO 13485, and other standard and regulatory requirements.
  • Lead assigned process improvement projects.
  • Lead root cause analysis and corrective/preventive actions (CAPA) for non-conformances and customer complaints for software design issues.
  • Support supplier quality management, including conducting sub-contractors and component supplier audits.
  • Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and software.
  • Collaborate with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure quality considerations are integrated throughout the product lifecycle.
  • All other duties as assigned.

 

About You:

  • Minimum 5 years direct experience working with FDA QSR and ISO 13485 in a QE role.
  • Bachelor’s degree in Mechanical, Biomedical, Electrical, Software, or Systems Engineering or related field or equivalent work experience.
  • Experience in software validation, product development and NPI and design transfers in the medical device industry.
  • Working knowledge of applicable medical device regulatory standards i.e.: FDA 21CFR 820, ISO 13485, IEC 62304, IEC 60601, ISO 14971, etc.
  • Expertise in common risk management techniques, e.g.: FTA, FMEA, Hazard Analysis, etc.

 

Preferred Qualifications:

  • SolidWorks CAD proficiency
  • Demonstrable proficiency in statistical data analysis methods / tools, e.g.: Gage R&R, Hypothesis Testing, Tolerance Interval Analysis, Acceptance Sampling, statistical process control, control charts, CpK’s, etc. using Minitab, JASP, SAS or similar data analysis packages.

 

Knowledge, Skills and Abilities:

  • Excellent verbal and written communication skills.
  • Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
  • Highly collaborative both within the function and with other functions.
  • Strong interpersonal skills with ability to work both independently and as part of a team.
  • Self-initiator, results driven and action & detail oriented.

 

Working Conditions:

  • Goddard is a product development/contracting professional services organization.  As such, it’s expected that travel to a client’s site to support project needs will be expected.  Travel time is rarely more than an hour commute from the company location.
  • This is a hybrid office/remote position with a minimum expectation of 3 days in the office and 2 days working remotely

 

Our Benefits:

  • Competitive Compensation: Receive a comprehensive reward package that includes a competitive salary, bonus, benefits, and opportunities for growth.
  • Flexible Time off: Enjoy some well-deserved rest and relaxation with our Flexible Time off Schedule and 10 paid Holidays.
  • Retirement Savings: Invest in your future with a 401(k) retirement plan with profit sharing contribution
  • Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family.
  • Family Support: We are in support of establishing Families, Goddard offer 6 Weeks Fully Paid parental leave with support of PFML state programs. 
  • Community Engagement: Connect with colleagues through regular company and team events, such as our Social hour Thursdays and local celebrations.

 

Goddard Technologies, Inc. is an equal opportunity employer. We embrace diversity and are committed to creating an inclusive environment for all employees.

 

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